1. Field of the Invention
This invention relates to a vial access adapter connected to a vial which contains a medical fluid therein and is closed by an elastomeric stopper, wherein the vial access adapter is provided with a dual spike, one for withdrawing the medical fluid from the vial, and the other for simultaneous entry of air into the vial.
2. Reported Developments
Vials made of glass or polymeric materials, the walls of which are non-collapsible, require an air inlet when medical fluid is withdrawn therefrom to prevent the formation of vacuum therein. Typically, vials containing a medical fluid are closed by rubber stoppers which are pierced by a dual spike having a medical fluid passage and an air inlet passage, therein. The air inlet passage contains a filter to prevent entry of particulate matter or bacteria into the vials during the medicament withdrawal process.
The prior art has provided devices comprising a liquid flow passage and an air flow passage, such as disclosed, for example, in U.S. Pat. Nos. 3,359,977, 3,608,550, 3,783,895, 4,262,671, 4,505,709, 4,588,403, 4,787,898, 5,358,501, and 5,636,660. These inventions have advanced the prior art by providing convenient adapters and transfer devices connectable to containers of medical fluids.
In addition to providing in a vial access adapter, a dual spike for withdrawing a medical fluid from a vial and simultaneously introducing filtered atmospheric air into the vial, the present invention also provides an elastomeric seal positioned in the fluid passage flow of the dual spike for hermetically sealing the fluid flow passage. In a preferred embodiment the elastomeric seal is of an M-shaped configuration through which the medical fluid can be accessed repeatedly. After each withdrawal of the desired amount the medical fluid the elastomeric seal reseals itself thereby preventing contamination of the medical fluid by air-born particles, such as dust and bacteria.
A further improvement in the present invention over the prior art is the spatial configuration of the medical fluid access spike which, on positioning of the vial access adapter over a vial having a rubber stopper, allows essentially complete withdrawal of the medical fluid contained in the vial.
The present invention comprises a first embodiment and a second embodiment. In the first embodiment the medical fluid access spike penetrates the rubber stopper and just clears the bottom surface of the rubber stopper. The vial, to which the vial access adapter is attached, is turned upside down during the withdrawal process. In the second embodiment the medical fluid access spike penetrates the rubber stopper and extends to the bottom of the vial. The vial in this embodiment is held in an upright position during the withdrawal process. Both embodiments allow essentially complete withdrawal of the medical fluid contained in the vial.
In accordance with the first embodiment of the present invention, there is provided a vial access adapter for use with a glass vial or a rigid or semi-rigid polymeric vial containing a liquid medicament, diagnostic agent, or nutritional formulation therein. The vial access adapter body comprises:
a horizontal top wall having a plurality of vent holes therein;
a horizontal second wall spaced parallel from the horizontal top wall;
a cylindrical side wall integral with the horizontal top wall and the horizontal second wall enclosing a chamber therebetween and extending downward from the horizontal second wall forming a skirt and terminating in a bottom rim;
a first spike centrally located in the vial access adapter body having a top portion extending above the horizontal wall and terminating in an externally threaded luer connector, and a bottom portion extending downward and terminating in a sharp point;
a fluid flow channel in the first spike designed for carrying the liquid medicament;
a second spike positioned parallel to the first spike extending downward from the horizontal second wall and terminating in a sharp point;
an air flow channel in the second spike designed for air flow from the chamber between the horizontal top wall and the horizontal second wall into the vial during withdrawal of the liquid medicament from the vial; and
an elastomeric membrane within the luer connector for sealing the fluid flow channel.
Preferably, the elastomeric membrane reseals itself upon repeated penetration by an external luer connector and allows repeated withdrawal of the liquid medicament from the vial without risk of contamination from atmospheric environment.
In accordance with the second embodiment of the present invention, there is provided a vial access adapter used in combination with a glass vial or a rigid or semi-rigid polymeric vial containing a liquid medicament, diagnostic agent, or nutritional formulation therein. The vial comprises:
a cylindrical side wall;
a flat bottom portion; and
a constricted neck portion terminating in a rim.
The constricted neck portion and the rim define an open area which is closed by an elastomeric stopper hermetically sealing the content of the vial. The elastomeric stopper comprises a cylindrical side wall and flat op and bottom surfaces.
The vial access adapter is designed to be placed on the constricted neck portion of the vial and to pierce the elastomeric spike by a dual spike, one serving as a fluid flow channel and the other as an air flow channel. The vial access adapter, having a vial access adapter body, comprises:
a horizontal top wall having a plurality of vent holes therein;
a horizontal second wall spaced parallel from the horizontal top wall;
a cylindrical side wall integral with the horizontal top wall and the horizontal second wall enclosing a chamber therebetween and extending downward from the horizontal second wall forming a skirt and terminating in a bottom rim;
a first spike centrally located in the vial access adapter body having a top portion extending above the horizontal wall and terminating in an externally threaded luer connector, and a bottom portion extending downward to the flat bottom portion of the vial and terminating in a sharp point;
a fluid flow channel in the first spike adapted to carry the liquid medicament from the vial;
a second spike positioned parallel to the first spike extending downward from the horizontal second wall and terminating in a sharp point, said second spike extending just below the bottom surface of the elastomeric stopper;
an air flow channel in the second spike designed for air flow from the chamber between the horizontal top wall and the horizontal second wall into the vial during withdrawal of the liquid medicament from the vial; and
an elastomeric membrane within the luer connector for sealing the fluid flow channel.
Preferably, the elastomeric membrane reseals itself upon repeated penetration by an external luer connector and allows repeated withdrawal of the liquid medicament from the vial without risk of contamination from atmospheric environment.
The vial and vial access adapter combination provides a delivery system for a medical fluid from the vial wherein the vial is in an upright position during the withdrawal process by the use of a luer-equipped syringe allowing complete or close to complete withdrawal of the medical fluid from the vial. The combination requires matching the height of the vial with the length of the fluid flow channel for complete or close to complete withdrawal of the medical fluid from the vial: each vial access adapter is xe2x80x9cdedicatedxe2x80x9d to the particular height of the vial. If the height of the vial is not precisely matched with the length of the fluid channel flow spike, less than complete withdrawal of the medical fluid from the vial is achieved.